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Natural History of Isolated Deep Vein Thrombosis of the Calf (CALTHRO)
| Tracking Information | ||||
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| First Received Date ICMJE | January 2, 2009 | |||
| Last Updated Date | September 17, 2009 | |||
| Start Date ICMJE | September 2005 | |||
| Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Thrombotic complications (deep vein thrombosis and/or pulmonary embolism within three months from first examination [ Time Frame: three months from first examination ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00816920 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
other vascular complications; how many isolated distal DVT will be diagnosed [ Time Frame: three months from first examination ] | |||
| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Natural History of Isolated Deep Vein Thrombosis of the Calf | |||
| Official Title ICMJE | Diagnosis and Evolution of Isolated Deep Vein Thrombosis of the Calf in Symptomatic Outpatients. The Blind, Prospective "CALTHRO" Study. | |||
| Brief Summary | Whether isolated distal DVT (IDDVT), DVT confined to the calf, should be looked for and diagnosed to allow them to be treated with anticoagulants remains one of the still unsolved issues in vascular medicine, especially because of the insufficient data on clinical risks of untreated distal DVT. Management studies have shown that it is safe to withhold anticoagulation in outpatients with suspected DVT if compression ultrasonography (CUS) limited to the proximal deep veins yields normal results on presentation and on repeated examination after 5 to 7 days. This strategy is based on the premise that IDDVT do not need to be diagnosed and treated, what is necessary when they extend involving the proximal veins. There is no general agreement, however, on the assumption that the non-extending IDDVT do not need to be diagnosed and treated, and many authors recommend to perform a single CUS examination extended to the distal deep veins. All the available studies have treated with anticoagulants the diagnosed IDDVT and no adequate information is available on the risk of IDDVT left untreated. The present study, performed in outpatients with suspected leg DVT, aims at assessing the clinical consequences of IDDVT diagnosed (by a complete US investigation) but not treated because the results of this investigation remain blind to both the patient and the treating doctor, whereas the diagnostic-therapeutic procedure remains the usual one, based on CUS investigation limited to diagnose proximal DVT, to be repeated after 5-7 days (or earlier) to exclude an extension to proximal veins of an IDDVT potentially present. |
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| Detailed Description | Outpatients symptomatic for suspected DVT of a leg are examined by a vascular doctor according to standard procedure based on pre-test clinical probability (PTCP) assessment, D-dimer assay and a CUS limited to the proximal deep veins. Those in whom a proximal DVT is excluded and have intermediate/high PTCP or altered D-dimer level are eligible for the study. The included patients are immediately submitted to an extensive echo-color-Doppler examination of calf deep veins by a different vascular doctor and results are closed in an envelope that will be open after three months (or before if necessary). In the meantime, patients will follow the standard diagnostic procedure: they receive an appointment to come back in 5-7 days for a further CUS examination, or even before in case of worsening of symptoms/signs. All the included patients receive a telephone call after three months to exclude possible complications. | |||
| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | outpatients with suspected deep vein thrombosis (DVT) of a leg in whom a proximal DVT is excluded. The study is not funded. As a result, it will not be possible to enroll all consecutive eligible patients; rather patients will be included based on the availability of expert medical staff in the day of their presentation (in general the first patient of the day). |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Ultrasound examination of leg veins
Outpatients symptomatic for leg DVT follow the standard diagnostic procedure (ultrasound examination of proximal deep veins, pre-test clinical probability and D-dimer, and a second US after 5-7 days) to exclude proximal DVT; they also receive by another doctor a complete US examination of the deep leg veins to assess the presence of isolated calf DVT, the results of the latter examination are kept blind to the patient and to the treating doctor, and disclosed after three months |
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| Study Groups/Cohorts | 1
Outpatients with suspected leg DVT after exclusion of proximal DVT
Intervention: Other: Ultrasound examination of leg veins |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 500 | |||
| Completion Date | September 2009 | |||
| Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Italy | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00816920 | |||
| Other Study ID Numbers ICMJE | 24/2001/O EM60/2007/O | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Gualtiero Palareti, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi | |||
| Study Sponsor ICMJE | St. Orsola Hospital | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | St. Orsola Hospital | |||
| Verification Date | September 2009 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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